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Last Updated: August 12, 2020

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ERIVEDGE Drug Profile

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When do Erivedge patents expire, and when can generic versions of Erivedge launch?

Erivedge is a drug marketed by Genentech and is included in one NDA. There are two patents protecting this drug.

This drug has fifty patent family members in twenty-four countries.

The generic ingredient in ERIVEDGE is vismodegib. One supplier is listed for this compound. Additional details are available on the vismodegib profile page.

US ANDA Litigation and Generic Entry Outlook for Erivedge

Erivedge was eligible for patent challenges on January 30, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 11, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for ERIVEDGE
Drug Prices for ERIVEDGE

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Generic Entry Opportunity Date for ERIVEDGE
Generic Entry Date for ERIVEDGE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ERIVEDGE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
GlaxoSmithKlinePhase 2
Ulrik LassenPhase 2
Columbia UniversityPhase 2

See all ERIVEDGE clinical trials

Pharmacology for ERIVEDGE

US Patents and Regulatory Information for ERIVEDGE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genentech ERIVEDGE vismodegib CAPSULE;ORAL 203388-001 Jan 30, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genentech ERIVEDGE vismodegib CAPSULE;ORAL 203388-001 Jan 30, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ERIVEDGE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1789390 SPC/GB13/060 United Kingdom   Start Trial PRODUCT NAME: VISMODEGIB OPTIONALLY IN THE FORM OF A SALT OR SOLVATE; REGISTERED: CH IKS-NO.62497 20130530; UK EU/1/13/848-EMEA/H/C 20130712
1789390 C20130027 00083 Estonia   Start Trial PRODUCT NAME: VISMODEGIIB;REG NO/DATE: K(2013)4550 (LOPLIK) 12.07.2013
1789390 C300614 Netherlands   Start Trial PRODUCT NAME: VISMODEGIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/13/848 20130712
1789390 PA2013024,C1789390 Lithuania   Start Trial PRODUCT NAME: VISMODEGIBUM; REGISTRATION NO/DATE: EU/1/13/848 20130712
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Mallinckrodt
Boehringer Ingelheim
McKesson
Colorcon
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.